Medication Adherence in Psoriatic Arthritis

NCT ID: NCT05223062

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-18

Study Completion Date

2022-08-15

Brief Summary

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Psoriatic arthritis (PsA) is a chronic multisystemic disease requiring ordinary doctor visits and an adherence to medication. Evaluating the parameters affecting the medication adherence is essential for the efficacy of the treatment. To our knowledge no study has ever evaluated the factors affecting the medication adherence in patients with PsA so far.

Detailed Description

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Psoriatic arthritis (PsA) is a multisystemic disease requiring ordinary doctor visits and an adherence to medication. Due to its chronic nature treatment regimens lasts for the lifetime and that may affect the efficacy of the treatment. Although treatment with drugs is a biological intervention, medication adherence and eliminating the factors affecting it seems essential for treatment efficacy. To our knowledge no study has ever evaluated the factors affecting the medication adherence in patients with PsA so far. Our aim in this study is to evaluate the factors affecting the medication adherence in patients with PsA.

Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Psoriatic arthritis

Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).

Disease activity in psoriatic arthritis (DAPSA)

Intervention Type OTHER

DAPSA includes a 68/66 joint count summed with a patient global, patient pain score, and C- reactive protein level. The DAPSA provides a continuous score of arthritis activity and has validated cut points for remission (\< 4) and low disease activity (\< 14).

Compliance-Questionnaire-Rheumatology (CQR)

Intervention Type OTHER

The CQR is a self-administered questionnaire that was developed with the aim of correctly identifying patients that were classified as "low" adherers (taking \<80% of their medication correctly). The four point Likert answering scale ranges from; "Definitely don't agree" (scored 1) to "Definitely agree" (scored 4) with lower scores indicating lower levels of adherence. Total score is between 0 and 100.

The Brief Illness Perception Questionnaire (BIPQ)

Intervention Type OTHER

The Brief Illness Perception Questionnaire (BIPQ) is a questionnaire that assesses a number of beliefs about illness which are thought to be related to coping and help-seeking behavior. Each item is scored between 0 and 10. Maximum total score is 80. Higher scores represents that the patient has a concerned perception of illness.

The Beliefs About Medicines Questionnaire (BMQ)

Intervention Type OTHER

The Beliefs About Medicines Questionnaire (BMQ) is a tool for evaluating people's beliefs about medicines. The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about medicines in general. It has a total of 18 questions scored with a 5-point Likert scale. Higher scores represent more powerful beliefs.

Hospital Anxiety and Depression Scale (HADS)

Intervention Type OTHER

Hospital Anxiety and Depression Scale (HADS) determines the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

The Psoriatic Arthritis Quality of Life (PsAQoL)

Intervention Type OTHER

The Psoriatic Arthritis Quality of Life (PsAQoL) measure is a disease specific patient-reported outcome measure which measures the effect that psoriatic arthritis has on a patient's quality of life. It is a self-administered, 20-item questionnaire that takes about three minutes to complete. The answers are restricted to true or false.A high score on the PsAQoL indicates a lower quality of life. Total score is between 0 and 20.

Interventions

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Disease activity in psoriatic arthritis (DAPSA)

DAPSA includes a 68/66 joint count summed with a patient global, patient pain score, and C- reactive protein level. The DAPSA provides a continuous score of arthritis activity and has validated cut points for remission (\< 4) and low disease activity (\< 14).

Intervention Type OTHER

Compliance-Questionnaire-Rheumatology (CQR)

The CQR is a self-administered questionnaire that was developed with the aim of correctly identifying patients that were classified as "low" adherers (taking \<80% of their medication correctly). The four point Likert answering scale ranges from; "Definitely don't agree" (scored 1) to "Definitely agree" (scored 4) with lower scores indicating lower levels of adherence. Total score is between 0 and 100.

Intervention Type OTHER

The Brief Illness Perception Questionnaire (BIPQ)

The Brief Illness Perception Questionnaire (BIPQ) is a questionnaire that assesses a number of beliefs about illness which are thought to be related to coping and help-seeking behavior. Each item is scored between 0 and 10. Maximum total score is 80. Higher scores represents that the patient has a concerned perception of illness.

Intervention Type OTHER

The Beliefs About Medicines Questionnaire (BMQ)

The Beliefs About Medicines Questionnaire (BMQ) is a tool for evaluating people's beliefs about medicines. The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about medicines in general. It has a total of 18 questions scored with a 5-point Likert scale. Higher scores represent more powerful beliefs.

Intervention Type OTHER

Hospital Anxiety and Depression Scale (HADS)

Hospital Anxiety and Depression Scale (HADS) determines the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

Intervention Type OTHER

The Psoriatic Arthritis Quality of Life (PsAQoL)

The Psoriatic Arthritis Quality of Life (PsAQoL) measure is a disease specific patient-reported outcome measure which measures the effect that psoriatic arthritis has on a patient's quality of life. It is a self-administered, 20-item questionnaire that takes about three minutes to complete. The answers are restricted to true or false.A high score on the PsAQoL indicates a lower quality of life. Total score is between 0 and 20.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with PsA according to CASPAR criteria
* Administering PsA medication for at least 6 moths
* Aged ≥18

Exclusion Criteria

* Not having enough cognitive functions to understand and answer the questionnaires
* Having a psychiatric disorder
* Having a severe comorbidity (e.g. malignancy, stroke)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Hromadkova L, Soukup T, Vlcek J. Quality of life and drug compliance: their interrelationship in rheumatic patients. J Eval Clin Pract. 2015 Oct;21(5):919-24. doi: 10.1111/jep.12399. Epub 2015 Jun 17.

Reference Type BACKGROUND
PMID: 26083391 (View on PubMed)

Tolu S, Rezvani A, Karacan I, Bugdayci D, Kucuk HC, Bucak OF, Aydin T. Self-Reported Medication Adherence in Patients With Ankylosing Spondylitis: The Role of Illness Perception and Medication Beliefs. Arch Rheumatol. 2020 Feb 7;35(4):495-505. doi: 10.46497/ArchRheumatol.2020.7732. eCollection 2020 Dec.

Reference Type BACKGROUND
PMID: 33758806 (View on PubMed)

Other Identifiers

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2021/263

Identifier Type: -

Identifier Source: org_study_id

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